Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients

Diabetes Clinical Trial

Official title:

Randomized Study Comparing Clinical and Microbiological Efficacy of Timentin Delivered Via Percutaneous Isolated Limb Perfusion (PILP) or Intravenous Infusion in Diabetic Subjects With Moderate to Severe Lower Limb Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02158442
• Other study ID #: O-PILP-C01 - Part B
• Status: Recruiting
• Phase: Phase 2
• First received: April 11, 2014
• Last updated: June 5, 2014
• Start date: October 2013
• Est. completion date: February 2015

Study information

• Verified date: June 2014
• Source: Osprey Medical, Inc
• Contact: Paul Wraight, Assoc. Prof.
• Phone: 61 3 93427000
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes who have a significant lower limb infection and it is deemed that IV antibiotics are needed in order to salvage the limb or life.

Description:

During the PILP procedure, the circulation of the limb is isolated separately from the general circulatory system thereby enabling the delivery of antibiotics only to the limb. Limb isolation is achieved by creating an "artificial" circuit where catheters are inserted into the major artery and vein of the lower limb.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• M or F subjects 18 - 90 years old

• Subject has pre-existing diabetes diagnosis

• Subject has significant infection below the ankle of soft tissue and may include bone, and IV antibiotics are needed in order to salve limb or life

• Consequence of infected wound would require Std of Care share debridement

• Subject willing and able to provide written informed consent

• Subject willing and able to comply with requirements of study protocol including pre-defined follow-up evaluations

• PROCEDURAL INCLUSION CRITERIA: successful cannulation of the femoral artery and vein and placement of the venous support device

Exclusion Criteria:

• Allergy to contrast media

• Known bleeding disorder including thrombocytopenia

• Recent AMI or elevated Troponin levels within last 30 days

• Penicillin sensitivity; Timentin sensitivity

• Female subjects known to be or suspected to be pregnant or lactating

• Subject unable to comply with instructions; especially to remain supine for duration of recirculation procedure

• Subjects who have participated in any other clinical trial or taken investigational drug within 30 days of study enrollment

• The PI determines the subject is not an appropriate subject for the study

• PROCEDURAL EXCLUSION CRITERIA: Subjects anatomy interferes with or is expected to prohibit successful cannulation of the femoral vessels or placement of the venous support device

• Known severe proximal femoral artery vascular disease precluding placement of perfusion catheters

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Infection

Intervention

Procedure:
• Percutaneous Isolated Limb Perfusion (PILP) delivery intervention
The Percutaneous Isolated Limb Perfusion (PILP) delivery intervention procedure enables the use of existing antibiotic therapies in a more targeted and aggressive fashion; it addresses limitations associated with the use of conventional antibiotic drug delivery. As part of the procedure, the circulation of the limb is isolated separately from the general circulatory system enabling the delivery of antibiotic at high therapeutic doses that are not achievable when standard doses are administered intravenously.

Drug:
• Timentin

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Parkville	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Osprey Medical, Inc	Osprey Medical Pty, Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of microbiological load in diabetic subjects with significant lower limb infections including assessment of CFU, infection type and antibiotic (Timentin) sensitivity between two groups over time.		Screening	Yes
Primary	Reduction of microbiological load in diabetic subjects with significant lower limb infections including assessment of CFU, infection type and antibiotic (Timentin) sensitivity between two groups over time.		Day 1 (assessment/procedure)	No
Primary	Reduction of microbiological load in diabetic subjects with significant lower limb infections including assessment of CFU, infection type and antibiotic (Timentin) sensitivity between two groups over time.		Day 2 post-procedure	Yes
Primary	Reduction of microbiological load in diabetic subjects with significant lower limb infections including assessment of CFU, infection type and antibiotic (Timentin) sensitivity between two groups over time.		Day 3 post-procedure	Yes
Primary	Reduction of microbiological load in diabetic subjects with significant lower limb infections including assessment of CFU, infection type and antibiotic (Timentin) sensitivity between two groups over time.		Day 7 post-procedure	Yes
Primary	Reduction of microbiological load in diabetic subjects with significant lower limb infections including assessment of CFU, infection type and antibiotic (Timentin) sensitivity between two groups over time.		Day 28 post-procedure	Yes